Stiefel Research Australia Pty Ltd

Stiefel West Coast LLC

Phoebe Sun

Albert Zorko Abram

Michael Johnston

Maria Graziella Larm

Ronald Harding

Prema Vijayakumar

Prema Viyayakumar

An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of desonide is provided, along with a method of medical or cosmetic treatment of a dermal condition using the composition. The composition includes desonide; an oil phase dispersed throughout a water phase, the oil phase including at least one member selected from the group consisting of an animal oil, a mineral oil, a vegetable oil, a silane member, a siloxane, an ester, a fatty acid, a fat, a halogen compound, and an alkoxylated alcohol; and at least one lipophilic surfactant, the water phase including at least one hydrophilic surfactant and water; and a non-surfactant amphiphilic compound that is miscible in the water phase and added to the composition after formation of the microemulsion or sub-micron emulsion; wherein the desonide is in the water phase or both the water phase and the oil phase.

Microemulsion and sub-micron emulsion process and compositions

An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of at least one pharmaceutically active ingredient, is provided. The composition includes an oil phase dispersed throughout a water phase, the oil phase including at least one member selected from the group consisting of an animal oil, a mineral oil, a vegetable oil, a silane member, a siloxane, an ester, a fatty acid, a fat, a halogen compound, and an alkoxylated alcohol; and at least one lipophilic surfactant, the water phase including at least one hydrophilic surfactant, water and optionally a non-surfactant amphiphilic compound, the weight ratio of the at least one hydrophilic surfactant to the at least one lipophilic surfactant being approximately 9.0:1.0 to 2.0:3.0.

An oil-in-water microemulsion or sub-micron emulsion composition for dermal delivery of at least one pharmaceutically active ingredient, comprising: a first part including at least one occlusive agent and one or more lipophilic surfactants dispersed throughout a second part including water and at least one hydrophilic surfactant, and a non-surfactant amphiphilic type compound, pharmaceutically active ingredient, and water. It has been found that if a non-surfactant amphiphilic type compound is added together with the second part as would conventionally be the case, a microemulsion or sub-micron emulsion is not formed, by adding the so called third part, phase assembly occurs at a lower temperature than would be expected and moreover, this phase appears to assist in maintaining the microemulsion or sub-micron emulsion characteristics of the formulation during storage at normal temperatures.

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Mountain View, CA, United States of America

Phoebe Sun